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Resilient clinical trial infrastructure in response to the COVID-19 pandemic: Lessons learned from the TOGETHER randomized platform clinical trial

In 2020, clinical trial researchers developed protocols to evaluate the safety and effectiveness of potential treatments for COVID-19. Despite more than 3,000 trials registered , few have generated findings, with the exception of smaller randomized controlled trials.A clinical trial infrastructure (defined as the human, material, and knowledge networks that form a responsive implementation of productive trial protocols) must be resilient to threats (e.g., COVID-19), and is essential when barriers to sustainable funding are common.

Interferon treatments for SARS-CoV-2: Challenges and opportunities

Interferon (IFN) therapies are used to treat a variety of infections and diseases and could be used to treat SARS-CoV-2. However, optimal use and timing of IFN therapy to treat SARS-CoV-2 is not well documented. We aimed to synthesize available evidence to understand whether interferon therapy should be recommended for treatment compared to a placebo or standard of care in adult patients.While IFN therapy has the potential to be a viable treatment for SARS-CoV-2, especially when combined with antivirals and early administration, the lack of comparable of study outcomes prevents evidence synthesis and uptake.

Ivermectin

Effect of early treatment with ivermectin among patients with covid-19

The efficacy of ivermectin in preventing hospitalization or extended observation in an emergency setting among outpatients with acutely symptomatic coronavirus disease 2019 (Covid-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is unclear.

Evaluating COVID vaccines in the real world

The effectiveness of the mRNA vaccines in preventing COVID-19 disease progression in 2021 set new expectations about the role of prevention interventions for the disease. Efficacy observed in the trials was more than 90%.1, 2 The efficacy of other vaccines evaluated in large randomised trials, such as the Oxford–AstraZeneca (70%) and Sputnik V (91%) vaccines, have been criticised for elements of the trial conduct and concerns about safety.3, 4 For that reason, mRNA vaccines have been most widely distributed in wealthier settings while other vaccines, such as Sinopharm and Sinovac, with some exceptions,3 have been provided in low-income and middle-income countries. The opportunity for head-to-head clinical trials evaluating vaccine comparative effectiveness no longer exists because so many people have received at least one dose of a vaccine. What happens in a clinical trial might also differ from the experiences of actual vaccine programmes and roll-outs. Until now, the real-world effectiveness of these lower profile vaccines has not been well established.

Metformin

Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial

In this randomized trial, metformin did not provide any clinical benefit to ambulatory patients with COVID-19 compared to placebo, with respect to reducing the need for retention in an emergency setting or hospitalization due to worsening COVID-19. There were also no differences between metformin and placebo observed for other secondary clinical outcomes.

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